Temozolomide in Treating Patients With Brain Metastases
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|ClinicalTrials.gov Identifier: NCT00005954|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have brain metastases.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: temozolomide||Phase 2|
- Determine the activity of temozolomide in patients with brain metastases.
- Determine the toxicity of this treatment in these patients.
OUTLINE: Patients are stratified according to type of primary cancer (lung carcinoma vs breast carcinoma vs malignant melanoma vs renal cell carcinoma vs colorectal carcinoma vs other).
Patients receive oral temozolomide daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 180 patients (30 per stratum) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Treatment of Adults With Brain Metastases With Temodar|
|Study Start Date :||August 2000|
|Actual Study Completion Date :||June 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005954
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Henry S. Friedman, MD||Duke University|